{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2026-21046", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260416", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20260320", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260416", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20190322", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "956874", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260416", "brand_name": "DA VINCI SP", "generic_name": "VISION SYSTEM CART", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380941-34", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20260401", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874114742", "udi_public": "(01)00886874114742", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Visual Prompts will not Clear" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/21/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260601", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260416", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "49 YR", "patient_sex": "Male", "patient_weight": "60 KG", "patient_ethnicity": "Hispanic", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20260514", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24899158", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260320", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "401687669", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: H2, H6, H11. ADDITIONAL INFORMATION: THE VIDEO PROCESSOR (VP) UNIT WAS RETURNED FOR FAILURE ANALYSIS (FA), AND THE REPORTED EVENT WAS NOT ABLE TO BE CONFIRMED OR REPLICATED. SYSTEM LOGS WERE REVIEWED, AND NO ERROR WERE PRESENT IN RELATION TO THE VP. INITIAL VISUAL INSPECTION NOTED THE VP UNIT WAS RECEIVED WITH NO FILTER. THE UNIT WAS TESTED ON IN-HOUSE SYSTEMS AND POWER CYCLES OPERATIONS WERE PERFORMED. THE UNIT PERFORMED SUCCESSFULLY WITH NO ERROR CODES PRESENT." }, { "mdr_text_key": "401687670", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "398606729", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INTUITIVE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS ABLE TO BE REPLICATED. THE FSE REPLACED THE ENDOSCOPE CONTROLLER (EC) AND THE VIDEO PROCESSOR (VP). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE EC WAS RETURNED TO FAILURE ANALYSIS (FA), AND THE REPORTED PROBLEM COULD NOT BE REPLICATED, HOWEVER, SYSTEM LOGS DID CONFIRM AN ERROR INDICATING THE FAILURE OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO DAMAGE WAS OBSERVED ON THE INTERIOR OR EXTERIOR OF THE UNIT. FA OBSERVED NO PHYSICAL DAMAGE TO THE ENDOSCOPE RECEPTACLE. THE EC WAS INSTALLED ON THE GOLDEN SYSTEM AND FUNCTIONED AS EXPECTED. ALL NODES WERE PRESENT, AND THE IMAGE WAS CLEAR ON BOTH THE VISION SIDE CART (VSC) AND SURGEON CONSOLE CONTROLLER (SCC). THE LEDS ON THE ENDOSCOPIC CONTROLLER POWER DISTRIBUTION (ECPD) AND DUAL CAMERA INTERFACE BOARD (DCIB) WERE PRESENT. THEY SYSTEM WAS SET TO RUN 10 POWER CYCLES. AFTER TESTING, THE ERROR LOGS WERE INVESTIGATED, BUT NO ERROR WAS FOUND RELATED TO THE REPORTED EVENT. INTUITIVE HAS RECEIVED THE VP TO PERFORM FAILURE ANALYSIS. HOWEVER, AS OF THE DATE OF THIS REPORT, THE EVALUATION HAS NOT BEEN COMPLETED." }, { "mdr_text_key": "398606730", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AFTER THE START OF A DA VINCI-ASSISTED TONGUE BASE RESECTION PROCEDURE, THE VISION SIDE CART (VSC) WAS ENCOUNTERING REPEATED SYSTEM FAULTS. PRIOR TO CALLING THE INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE), THE SITE HAD ALREADY EXCHANGED THE SCOPE AND PERFORMED A HARD POWER CYCLE OF THE SYSTEM; HOWEVER, THE ISSUE DID NOT RESOLVE. THE PROCEDURE WAS ABORTED AFTER ANESTHESIA WAS ADMINISTERED BUT INCISION PORTS HAD NOT BEEN PLACED. THE CUSTOMER STATED THE PATIENT TOLERATED THE ABORTED PROCEDURE WITH NO REPORTED INJURIES OR POSTOPERATIVE COMPLICATIONS. THE SURGERY WAS RESCHEDULED AND COMPLETED 5 DAYS LATER." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/14/2026" } ] }